Field of the Invention
The present invention relates generally to the field of in-situ real-time invivo diagnostic tools, and specifically to real-time result Pap Smear Tests.
Background Description
There have been successful attempts to develop automated, computer Pap image analysis systems for screening. A recent NHS Health technology appraisal concluded that the general case for automated image analysis had probably been made. Automation may improve sensitivity and reduce unsatisfactory specimens. Two systems have been approved by the PDA and function In high-volume reference laboratories, with human oversight. While this is a good step in the right direction, what is needed is automation of the automation, the entire process and not just pieces. The Papanicolaou test AKA Pap test or Pap smear, cervical smear, or smear test is a method of cervical screening used to detect potentially pre-cancerous and cancerous processes in the endocervical canal, “transformation zone”, of the female reproductive system. Unusual findings are often followed up by more sensitive diagnostic procedures, and, if warranted, interventions that aim to prevent progression to cervical cancer Pap smears are a routine operation and needed by 100 million women in the U.S. each year. The minimum cost for a simple test with no complications is in the range of $30. This represents a minimum of a $3 Billion health care market for a simple Pap smear test alone.
The Pap smear process includes scheduled doctor intensive exam, in which a speculum is used manually and diagnostics follows but also done manually and may take weeks of time to schedule and complete. A smear is then sent to a lab for a specialist to analyze for pre-cancerous and cancerous cells. Other bacteria, fungus, virus or anomalies are screened and identified by inspection by a specialist. The smear is obtained manually via a tool called a speculum.
The best-known speculum is the bivalved vaginal speculum but a cylindrical-shaped speculum, introduced in 2001, the dilating vaginal speculum also known as the Veda-scope is also used, which inflates the vagina with filtered air. The device has two main functions: a) to take a normal PAP smear with a cervical brush or a cytology brush; and b) as an internal colposcope so that the operator can pivot the Veda-scope to view any part of the vagina barrel and cervix facilitated by an internal light source that can illuminate the vaginal wall and cervix with multi-colored light filters, which can detect pre-cancerous cells with the aid of acetic acid solution and solution. It also has a facility to attach a digital camera for viewing and recording.
Currently inspection of samples taken from a Pap test include Endocervical adenocarcinoma, Candide organisms, viral cytopathic effect consistent with herpes simplex virus, normal squamous epithelial cells in premenopausal women, atrophic squamous cells in postmenopausal women, the cytoplasms of squamous epithelial cells melted out Infestation by Trichomonas vaginalis, obviously atypical cell, HPV legions and other anomalous or symptomatic characteristics are found by inspection of Pap smears. Identification is through manual sampling and specialist inspection. Manual inspection and analysis of any of these have known and well used treatments. However human inspection and lab analysis is fallible, time consuming, and costly. Many of these can be discovered by image processing and comparison with standard known sample images in minutes.
The microbial offending life may reside inside of tissue on or below the tissue surface. Currently “scraping” instruments are used to make microscope slide samples which can be analyzed. What is needed are ways to find the offending organisms at what ever tissue level they reside without the use of “scraping” for lab test slides for microscopy scrutiny.
In the United States, a pap test itself costs $20 Co $30, but the costs for pap test visits can cost over $1,000, largely because additional tests are added that may or may slot be necessary, depending on the Pap smear test results. Results on occasion find human papillomavirus (HPV), a DNA virus which establish productive infections only in mucous membranes. Most HPV infections are subclinical and will cause no physical symptoms; however, in some people infections may cause benign squamous cell papilloma, or cancers of the cervix, vulva, vagina and other organs with mucous membranes. Out of the over a hundred variants. HPV16 and HPV18 are known to cause around 70% of cervical cancer cases. Surgical removal, topical creams and laser are the three methods currently used to excise these cancer agents. But Pap smears are the best and most used method for early detection of harmful HPV, followed by treatment if the HPV precancerous squamous cell is found. What is needed is a Pap test that give a woman all the results all at one time, so that follow-on procedures can be established with out undue time and cost escalation.
Recent advancements in photonic microscopy diagnostics, detection and imaging technologies have made inroads into computer image processing and automation. Theses are emerging technologies which can replace outdated medical diagnostic and treatment processes. Many medical procedures are time consuming, logistically challenging for medical staff and doctors driving up medical and health care costs. In addition many ailments and maladies can be diagnosed, identified and remedied, using similar tools, techniques and procedures. Technology used in analyzing tissue, assay and blood samples in the medical arena are growing, but they are not well integrated. Technology fiber optics and photonics, endoscopes and microscopes, instruments used to examine the interior cavity of the body or organ and other process require the obtaining of samples manually, physical examination of samples at laboratories for manual inspection by a specialist. Much of this labor can be integrated through digital imaging, software, optical microscopy, LED and laser technology.
Laparoscopy
While laparoscopy with the aid of a camera can either be used to inspect and diagnose a condition or to perform surgery, Pap smear samples and micrograph images are still done the old fashion way, by scraper. By and large laparoscopes are rigid endoscopes. The rigidness is required in clinical practice. The rod lens based laparoscopes are highly dominant in practice, due to their optical resolution of typically 50 μm, dependant on the aperture size used in the objective lens, and the image quality can be better than the digital cameras if necessary. The 1000× magnification is not possible with laparoscopes. What is needed are higher resolution and magnification laparoscopy.
Photonics and Microscopy
Digital and optical microscopy have also seen tremendous inroads in the medical fields. However a multidisciplinary approach involving the collaboration between clinicians and technology developers is necessary for the implementation of new medical devices. Change and adoption are faster when the antiquated manual process methods prove too expensive on patients as well as medical and health care staff. What is needed are ways to obtain and analyze bio-samples more quickly using faster developed technology programmatically.